Phase 4
N=184
Preoperative Antibiotics for Carpal Tunnel Release Surgery
Carpal Tunnel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03432858 ↗Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants With Surgical Site Infection — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vancomycin (Drug); Cefazolin (Drug); Saline Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- WellSpan Health
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Surgical Site Infection |
0; 0; 0 | — |
| PRIMARY Number of Participants With Surgical Site Infection |
0; 0; 0 | — |
| SECONDARY Number of Participants With Diabetes Diagnosis and Surgical Site Infection |
0; 0; 0 | — |
| SECONDARY Number of Participants With Diabetes Diagnosis and Surgical Site Infection |
0; 0; 0 | — |
| SECONDARY Number of Participants With Surgical Site Infections That Use Tobacco |
0; 0; 0 | — |
| SECONDARY Number of Participants With Surgical Site Infections That Use Tobacco |
0; 0; 0 | — |
| SECONDARY Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection |
0; 0; 0 | — |
| SECONDARY Number of Participants With Chronic Obstructive Pulmonary Disease Diagnosis and Surgical Site Infection |
0; 0; 0 | — |
| SECONDARY Number of Participants With Anemia Diagnosis and Surgical Site Infection |
0; 0; 0 | — |
| SECONDARY Number of Participants With Anemia Diagnosis and Surgical Site Infection |
0; 0; 0 | — |
| SECONDARY Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection |
0; 0; 0 | — |
| SECONDARY Number of Participants With Peripheral Artery Disease Diagnosis and Surgical Site Infection |
0; 0; 0 | — |
| SECONDARY Number of Participants With Surgical Site Infection and a History of Arthroplasty |
0; 0; 0 | — |
| SECONDARY Number of Participants With Surgical Site Infection and History of Arthroplasty |
0; 0; 0 | — |
| SECONDARY Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection |
0; 0; 0 | — |
| SECONDARY Number of Participants With Valvular Disease Diagnosis and Surgical Site Infection |
0; 0; 0 | — |
| SECONDARY Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release |
0; 0; 0 | — |
| SECONDARY Number of Participants With Surgical Site Infection That Underwent Single Incision Endoscopic Carpal Tunnel Release |
0; 0; 0 | — |
| SECONDARY Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release |
0; 0; 0 | — |
| SECONDARY Number of Participants With Surgical Site Infection That Underwent Double Incision Endoscopic Carpal Tunnel Release |
0; 0; 0 | — |
| SECONDARY Time From Last Cortisone Injection |
— | — |
| SECONDARY Time From Last Cortisone Injection |
— | — |
| SECONDARY Acuity of Carpal Tunnel Syndrome |
— | — |
| SECONDARY Acuity of Carpal Tunnel Syndrome |
— | — |
Summary
This is a clinical trial to determine how effective antibiotics administered prior to endoscopic carpal tunnel release surgery are in preventing surgical site infections.
Eligibility Criteria
Inclusion Criteria
- High probability (>12 points) on the Carpal Tunnel-6 diagnostic aide
- Recommendation for carpal tunnel release
- Capable of providing informed consent/LAR to act on subject's behalf
Exclusion Criteria
- Patients allergic to both penicillin/cephalosporins and vancomycin
- Patient immobilized with splint or cast
- Unwilling unable to provide informed consent
- Children under the age of 18
Data sourced from ClinicalTrials.gov (NCT03432858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.